ISET 2018: OPTALYSE PE trial reinforces safety and efficacy of EKOS therapy

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BTG reported that the OPTALYSE PE one-year trial results, presented at ISET (3–5 February, Hollywood, USA), confirm that bilateral pulmonary embolism patients treated in as little as two hours with a total tissue plasminogen activator (tPA) dose as low as 8mg continue to show improvements in right-to-left ventricular ratio over the long term.

Additionally, the all-cause mortality rate was very low (2%), as was recurrent pulmonary embolism ate of 2%, and continued quality of life improvements—further demonstrating the efficacy and safety of the OPTALYSE PE treatment regimens.

A press release states that the therapy used in the study—the EKOS system—uses ultrasonic waves in combination with clot-dissolving thrombolytic drugs to effectively dissolve clots and restore healthy heart function and blood flow.

The study authors followed the 12-month outcomes of 101 patients at 17 centres who participated in the OPTALYSE PE study in which the patients were randomised one of four cohorts. These patients were diagnosed with acute proximal pulmonary embolism in at least one main or proximal lobar pulmonary artery and a right ventricular-to-left ventricular diameter ratio greater or equal to 0.9 on chest computed tomography (CT) angiography. Patients received treatment within 48 hours of diagnosis. The four cohorts ranged from two to six hours in treatment duration and 8mg to 24mg total tPA for bilateral pulmonary embolism.

All cohorts saw a significant reduction in right-to-left ventricular ratio by approximately 23% to 26% taken via CT angiography at 48 hours. For follow-up, patients received echocardiograms at four hours, 48 hours, 30 days, 90 days, and at one year post-EKOS therapy. The initial significant reductions in right-to-left ventricular ratio continued to improve in all cohorts through one year—with mean right-to-left ventricular ratios in the 0.70 range at one year for all cohorts. Multiple quality of life measurements showed valuable improvements between 30 days and 365 days; further demonstrating the long-term benefit of EKOS therapy.

Principal investigator Victor Tapson (VTE and Pulmonary Vascular Disease Research Program at Cedars-Sinai Medical Center, Los Angeles, USA) says: “The long term follow-up results reinforce that a new interventional standard is being set for pulmonary embolism treatment. The 2% one-year all-cause mortality rate observed in OPTALYSE PE is much lower than the ~8% rate seen in comparable anticoagulation studies. This is important for institutions that are adopting the new low-dose, shorter duration treatments explored in OPTALYSE PE.”

A separate registry study, KNOCOUT PE is currently underway to measure how hospitals are adopting and benefiting from the new standard of care. At full enrolment, the KNOCOUT PE study is expected to include as many as 100 centres internationally.  Cases will include those from before and after the release of the original OPTALYSE PE study.

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